Anemia Management in Chronic Kidney Disease: A Comparative Evaluation of HIF-PHD Inhibitor(s) and ESAs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1. Change(s) in hemoglobin from baseline to 3
研究概览
简要总结
Chronic Kidney Disease (CKD) is a prevalent health condition worldwide, with a significant number of patients progressing to end-stage renal disease (ESRD) and requiring dialysis. Anemia is a common complication of CKD and is associated with a reduced quality of life, increased healthcare costs, and a higher risk of mortality.
Traditionally, erythropoiesis-stimulating agents (ESAs) have been the standard of care for managing anemia in CKD patients undergoing dialysis. However, emerging research has explored the potential of Hypoxia-Inducible Factor-Prolyl Hydroxylase Domain (HIF-PHD) inhibitors as an alternative treatment option. This research aims to provide valuable insights into the management of anemia in CKD patients undergoing dialysis. By comparing the effectiveness, safety, cost, HRQoL, and mortality. The outcomes of the research will contribute significantly to improve the overall care and informed decision-making process for healthcare providers and policymakers, for optimal treatment approaches for the patient population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who are diagnosed with CKD with renal anemia & undergoing dialysis B.
- •Patient should have been on dialysis for at least 3 months.
- •Patients between 18-75 years will receive HIF-PHD inhibitors or ESAs.
排除标准
- •Inability to give informed consent B.
- •Patients unable to complete the interview C.
- •Psychiatric illness D.
- •History of malignancy E.
- •Any active or recent history of blood loss F.
- •Taking part in other drug studies G.
- •Pregnant and breastfeeding women.
结局指标
主要结局
1. Change(s) in hemoglobin from baseline to 3
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
rd, 6th and 12th
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
months.
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
2. Changes in the iron utilization parameters, including
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin,
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
RET-He and relevant biochemistry laboratory results from
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
baseline.
时间窗: 1. Change(s) in hemoglobin from baseline to 3 | rd, 6th and 12th | months. | 2. Changes in the iron utilization parameters, including | serum iron, TIBC, TSAT, ferritin, EPO level, sTfR, Hepcidin, | RET-He and relevant biochemistry laboratory results from | baseline.
次要结局
- The secondary outcomes of the study will focus on the treatment-emergent adverse effects (TEATs) and serious adverse events, cardiovascular events, and hospitalization.(The study will report adverse events during the follow-up period, with a focus on drug discontinuation due to adverse events.)
研究者
Dr. Pramil Tiwari
National Institute of Pharmaceutical Education and Research (NIPER) Mohali